Robust Automation and Point of Care IDentification of COVID - Hospital Costa del Sol

he objetive of the study was the testing of a Point of Care (PoC) device, capable to sample to result in under 60 minutes. This device shall act as a front-line screening diagnostic for patients suspected of having SARS-CoV-2 infection and others pathogens, such as Influenza A and Influenza B. This device should be fully automated for sample extraction DNA/RNA amplification (“PCR”) and detection/data analysis steps. This solution will allow for effective triage of patients outside of central testing laboratories, including remote locations, A&E in hospitals, pandemic surveillance centres and border control disease detection centres. All samples were pre-diagnosed using the Xpert Xpress SARS-CoV-2 (Cepheid, Sunnyvale, CA USA), this is a comparator test with a similar response time and handling characteristics. Data was also collected on the limit of detection, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and reproducibility. The conclusions drawn from this study were that the global and stratified specificity were, in all cases, greater than 99%. The overall sensitivity of the EasyNAT SARS-CoV-2 Assay, when compared to the comparator assay, was 79.1%, which is considered as suboptimal. When stratifying the assay by type of preanalytical preservation it was found that the POC assay had a much greater sensitivity when testing fresh or recently extracted samples rather than samples which have been frozen. The concordance evaluation highlighted discordant results against the comparator assay, particularly when the comparator Ct values were high and therefore viral load is low, or if the samples are frozen. The Xpert Xpress SARS-CoV-2 failed to detect pathogens in these cases. The EasyNAT SARS-CoV-2 Assay could therefore be recommended for use with samples that have been drawn recently, kept refrigerated during transport, and is suspected of containing a high viral load (symptoms compatible with SARS-CoV-2 infection or have a recent positive antigen test).The assay is also favorable for carrying out rapid screening in patients with symptoms compatible with SARS-CoV-2 infection, including centers far from hospitals or in areas of difficult access, and health professionals or professionals from important sectors with a previous positive result and without current symptoms.

本研究旨在检验一种即时检测（PoC）设备，该设备可在60分钟内完成样本采集至结果输出。该设备将作为一线筛查诊断工具，用于疑似患有SARS-CoV-2感染及其他病原体，如甲型流感病毒和乙型流感病毒的患者的检测。该设备应实现样本提取、DNA/RNA扩增（PCR）以及检测/数据分析步骤的完全自动化。此方案将允许在中心检测实验室之外，包括偏远地区、医院的急诊室、大流行病监测中心和边境疾病检测中心等地方对患者进行有效分流。所有样本均使用Xpert Xpress SARS-CoV-2（Cepheid，Sunnyvale，CA，美国）进行预诊断，此为一项具有相似响应时间和操作特性的对照试验。同时，还收集了关于检测限、灵敏度、特异性、阳性预测值（PPV）、阴性预测值（NPV）和再现性的数据。研究结论指出，无论在何种情况下，全球性和分层特异性均大于99%。与对照试验相比，EasyNAT SARS-CoV-2检测的总体灵敏度仅为79.1%，被认为是不够理想的。通过对预分析保存类型的分层分析发现，对于新鲜或近期提取的样本，POC检测的灵敏度远高于已冷冻的样本。一致性评估指出，与对照试验存在不一致的结果，尤其是在对照Ct值较高且因此病毒载量较低，或样本被冷冻的情况下。Xpert Xpress SARS-CoV-2在这些情况下未能检测到病原体。因此，EasyNAT SARS-CoV-2检测可推荐用于近期采集、运输过程中保持冷藏且疑似含有高病毒载量（症状与SARS-CoV-2感染相符或近期抗原检测结果为阳性）的样本。该检测方法对于对疑似SARS-CoV-2感染症状的患者进行快速筛查也颇具优势，包括远离医院或难以到达的地区，以及之前检测结果为阳性且目前无症状的健康专业人员或重要行业专业人员。